Intracranial stent and method of use

ABSTRACT

A stent and stent catheter for intra-cranial use. The stent is a rolled sheet stent and is releasably mounted on the distal tip of the catheter with a low profile retaining tab. The stent is rolled tightly on the distal tip of the catheter and flexibility of the tightly rolled stent is promoted by ribbed or slatted construction (or, alternatively, slotted construction) in which the various layers of the stent are provided with numerous slats which counter align when the stent is expanded to form an imperforate wall from a plurality of perforate layers.

[0001] This application is a continuation of U.S. patent applicationSer. No. 09/474,050, filed Dec. 28, 1999, now U.S. Pat. No. 6,432,128,which is a continuation of U.S. patent application Ser. No. 08/707,996,filed Sep. 18, 1996, now U.S. Pat. No. 6,007,573.

FIELD OF THE INVENTION

[0002] This invention relates to treatments for vascular disease.

BACKGROUND OF THE INVENTIONS

[0003] The inventions described below were developed with the goal ofproviding new and better therapies for certain types of vascular diseasefor which the present day therapies are widely regarded as inadequate.Vascular disease includes aneurysms which can rupture and causehemorrhage, atherosclerosis which can cause the occlusion of the bloodvessels, vascular malformation and tumors. Occlusion of the coronaryarteries, for example, is a common cause of heart attack. Vesselocclusion or rupture of an aneurysm within the brain are causes ofstroke. Tumors fed by intra-cranial arteries can grow within the brainto the point where they cause a mass effect. The mass and size of thetumor can cause a stroke or the symptoms of stroke, requiring surgeryfor removal of the tumor or other remedial intervention.

[0004] Other therapies for occlusions of various arteries are underdevelopment. Balloon angioplasty is a technique in which a balloon isinserted into a stenosis which occludes or partially occludes an arteryand is inflated in order to open the artery. Atherectomy is a techniquein which occlusive atheromas are cut from the inner surface of thearteries. The newly preferred therapy for coronary occlusions isplacement of an expanded metal wire-frame, called a stent, within theoccluded region of the blood vessel to hold it open. Stents of variousconstruction have been proposed, including the Palmaz-Schatz™ balloonexpandable metal stent, the Wallstent self-expanding braided metalstent, the Strecker knitted metal stent, the Instent™ coil stent, theCragg coiled stent and the Gianturco Z stent. Stents have been proposedfor treatment of atherosclerosis in the neck, but carotid endarterectomyis still the preferred treatment for stenosis. Most perioperativestrokes are thought to be caused by technical errors duringendarterectomy (see Becker, Should Metallic Vascular Stents Be Used ToTreat Cerebrovascular Occlusive Disease, 191 Radiology 309 (1994)). Thesame concerns militate against other forms of therapy such asangioplasty for treatment of the carotid arteries. Various factors,including poor long-term patency, distal emboli causing a stroke, thepotential for crushing from external pressure, and the need for longterm anti-coagulation, lead to the avoidance of certain stents invessels smaller than the iliac arteries or in locations susceptible toexternal pressure. See, for example, Hull, The Wallstent in PeripheralVascular Disease, For Iliac Use Only, 6 JVIR 884 (Nov.-Dec. 1995).

[0005] Stent grafts have been proposed and used to treat aneurysms inthe large blood vessels such as the aorta, and these typically includetube graft material supported by a metallic stent. These stent graftsare designed for use in the large blood vessels, and the various layersof stents and grafts make them unsuitable for use in smaller bloodvessels. Stent grafts are not currently used in the coronary arterieswhich are typically 3 or 4 mm in internal diameter. Rolled stents havebeen proposed for use in aortic aneurysms. For example, Lane, SelfExpanding Vascular Endoprosthesis for Aneurysms, U.S. Pat. No. 5,405,379(Apr. 11, 1995) suggests the use of a polypropylene sheet placed in theabdominal or thoracic aorta to bridge aneurysms. It is particularlyemphasized in Lane that the rolled sheet must be imperforate. Winston,Stent Construction of Rolled Configuration, U.S. Pat. No. 5,306,294(Apr. 26, 1994) proposes a rolled sheet of stainless steel. Neitherdevice is believed to have been used or approved for use in humans. Ofsimilar construction are the single layer rolled stents such as Kreamer,Intraluminal Graft, U.S. Pat. No. 4,740,207 (Apr. 26, 1988) and itsreissue Re 34,327 (Jul. 27, 1993), which are expanded by balloon andinclude a ratchet mechanism which projects into the lumen of the stent,thus making it unsuitable for critical vessels in the brain and smalldiameter vessels. Khosravi, Ratcheting Stent, U.S. Pat. No. 5,441,155(Aug. 15, 1995) and Sigwart, Intravascular Stent, U.S. Pat. No.5,443,500 (Aug. 22, 1995) are other examples of rolled stents withratcheting locking mechanisms.

[0006] Aneurysms of peripheral arteries and arteries of the neck havebeen treated experimentally with open walled stents such as the Streckerbraided stent. Szikora, et al., Combined use of Stents and Coils totreat Experimental Wide-Necked Carotid Aneurysms, 15 AJNR 1091 (June1994) illustrates use of a Strecker stent in the proximal vertebralarteries in dogs, and teaches that an open walled or porous stent isrequired to avoid excessive ingrowth. The Strecker stent has a verysmall metal to blood vessel surface ratio, and has large openingsbetween each of the wires making up the stent. The current technique inthe use of open walled stents in the aneurysms of peripheral arteries isbased on the theory that placement of the open walled stent slows theblood flow in the aneurysmal sac, leading eventually to the formation ofclots and fibrous masses which occlude the aneurysm. This technique hasbeen combined with placement of micro-coils through the wall of thestent and into the aneurysm to further encourage fibrous tissuedevelopment within the aneurysm. The Szikora article and others showthat knitted stents have not been effective in isolating an aneurysmfrom the circulatory system. Another problem noted with this techniqueis that blood clots can escape the open walled stent.

[0007] Stents have not previously been used for aneurysms of the bloodvessels in the brain. The vessels in the brain likely to developstenosis, aneurysms, AVM's and side branches requiring occlusion havediameters of about 1 mm to 5 mm, and can be accessed only via highlytortuous routes through the vascular system. Instead, clipping,resection, complete occlusion with acrylic-based adhesives (super glue)or small balloons (thereby intentionally occluding the downstreamportion of the blood vessel and any portion of the brain supplied bythat portion), stuffing with foreign objects, etc. have been used. In amethod of current interest, small coils are stuffed into the aneurysmvia a catheter. One such small coil is known as the Guglielmi DetachableCoil or GDC. After placement of a few coils, which partially obstructblood flow in the aneurysm, the blood clots or fibrous matter formswithin the sac. This technique has reportedly resulted in clots andcoils falling out of the sac, and the technique is not used on wide-neckaneurysms. Aneurysm clipping, in which the skull is opened and the braindissected to expose the outside of the aneurysm, followed by placementof clips at the base of the aneurysm, is also an option for treatment.However, these techniques do not always effect an immediate and completeseal of the aneurysm from the high pressure of the circulatory system,and rupture, leakage and deadly complications occur. Aneurysm ruptureand bleeding during surgical clipping and shortly after the clipplacement is a significant problem and add difficulty to the procedure.Examples of the problems inherent in the use of both CDC's and aneurysmclips are illustrated in Civit, et al., Aneurysm Clipping AfterEndovascular Treatment With Coils, 38 Neurosurgery 955 (May 1996) whichreports that several patients in the study died after unsuccessful coilplacement and before they could be re-treated with the open skull clipplacement. Thus the article illustrates that GDC's do not always work,and when they fail they may leave the patient in a critical condition.As illustrated in the article, bleeding during surgical clipping andshortly after the clip placement is also a frequent problem.

[0008] From experiences like this, it is apparent that the ultimate goalof intracranial aneurysm treatment is the complete or nearly completeexclusion of the aneurysm cavity from the circulation, which preventsbleeding into the brain cavity and prevents formation of distal bloodclots. This goal may be achieved immediately to ensure successfultreatment by means of a substantially imperforate stent. It may also beachieved with a slightly perforated stent which alters flow in such away that compete clotting, over time, is initiated within the aneurysm.It may also be achieved with a perforate stent through which embolicmaterial such as coils are placed in the aneurysm. The treatments may beaccomplished by placement of the stents described below which generallydo not require the use of balloons for expansion of the stent, so thatthe blood vessel being treated is not occluded during placement of thestent.

SUMMARY

[0009] Stents for intra-cranial use and methods for using these stentsare described in detail below. The physical characteristics of prior artballoon expandable stents and self expanding stents make them clearlyunsuitable for intra-cranial use, because of their delivery profile andtendency to temporarily occlude the vessel during deployment. They havenot been proposed for intra-cranial use. Palmaz stents, Palmaz-Schatz™stents, Wall stents, Cragg stents, Strecker stents and Gianturco stentsand other stents are too rigid to allow placement in the cerebral bloodvessels, some require a balloon for deployment, and all are too open toocclude an aneurysm. Presented below are several embodiments of stentssuitable for intra-cranial use, along with methods for using thesestents to treat intra-cranial vascular disease.

[0010] The self expanding rolled sheet stent is suitable for use in theintra-cranial arteries. The rolled sheet is made of Elgiloy™, nitinol,stainless steel, plastic or other suitable material, and is impartedwith resilience to urge outward expansion of the roll to bring therolled stent into contact with the inner wall of a diseased artery. Therolled sheet is adapted for easy insertion and non-deforming radialflexibility to facilitate tracking along the tortuous insertion pathwaysinto the brain. In some embodiments, as much of the material of thestent is removed as is consistent with eventual creation of a solidwalled stent upon unrolling of the stent within the blood vessel. Theunrolled stent may be two or more layers of Elgiloy™, thus providingradial strength for the stent and creating at least a slight compliancemismatch between the stent and the blood vessel, thereby creating a sealbetween the stent and the blood vessel wall. For placement, the stent istightly rolled upon or captured within the distal tip of an insertioncatheter. The release mechanism is extremely low profile, and permitsholding the rolled stent in a tight roll during insertion and permitsatraumatic release when in the proximity of the site of arterialdisease, without occluding the vessel with the deployment catheter. Thestent can be placed in the intra-cranial blood vessels (arteries andveins) of a patient to accomplish immediate and complete isolation of ananeurysm and side branches from the circulatory system. The stent may beplaced across a target site such as an aneurysm neck, origin of afistula, or branch blood vessels feeding a tumor in order to redirectthe flow of blood away from the target. It can be used as a stand alonedevice which is left in the intra-cranial artery permanently, or it maybe used as a temporary device which allows for immediate stabilizationof a patient undergoing rupture of a blood vessel aneurysm or awaitingopen skull surgery for clipping or resection of an aneurysm. The stentcan be used for stabilization and isolation of a vascular defect duringsurgery of the vascular defect. Another advantage of this type of stentis that it can be wound down should repositioning be required prior tofull release. It is possible to rewind and reposition or remove thedevice using grasping tools.

BRIEF DESCRIPTION OF THE DRAWINGS

[0011]FIG. 1 is a schematic diagram of the vasculature of the brainshowing a typical placement of an intra-cranial stent.

[0012]FIG. 2 is schematic diagram of the vascular of the brainillustrating the circle of Willis and arteries supplying the circle ofWillis.

[0013]FIG. 3 is an elevational view of the rolled stent mounted on aninsertion catheter.

[0014]FIG. 4 is a cross section of a preferred embodiment of the stentcatheter.

[0015]FIG. 5 is a cross section of a second preferred embodiment of thestent catheter.

[0016]FIG. 6 is a cross section of a third preferred embodiment of thestent catheter.

[0017]FIG. 7 is a view of a simple embodiment of the stent.

[0018]FIG. 8 is a view of a preferred embodiment of the stent.

[0019]FIG. 9 is a view of a preferred embodiment of the stent.

[0020]FIG. 10 is a view of a preferred embodiment of the stent.

[0021]FIG. 11 is a view of a preferred embodiment of the stent.

[0022]FIG. 12 is a view of an alternative embodiment of the stent.

[0023]FIG. 13 is a view of an alternative embodiment of the stent.

[0024]FIG. 13a is a view of an alternative embodiment of the stent.

[0025]FIG. 14 is a view of an alternative embodiment of the stent.

[0026]FIG. 15 is a view of an alternative embodiment of the stent withslats running in the longitudinal direction.

[0027]FIG. 16 is a cross section of diseased artery with the stent inplace.

[0028]FIG. 17 is a sectional view of a diseased artery with the stentbeing used in conjunction with aneurysm clips.

[0029]FIG. 18 is a sectional view of a diseased artery with the stentbeing used in conjunction with detachable coils.

[0030]FIG. 19 is a view of an embodiment of the stent in place within adiseased artery.

[0031]FIG. 20 is a view of an embodiment of the stent in place within adiseased artery.

[0032]FIG. 21 shows and alternative embodiment of the stent.

[0033]FIG. 22 is a view of an embodiment of the stent in place within adiseased artery.

[0034]FIG. 23 shows an alternative embodiment of the stent.

[0035]FIG. 24 shows an alternative embodiment of the stent in placewithin a diseased artery

DETAILED DESCRIPTION OF THE INVENTIONS

[0036]FIGS. 1 and 2 show the vasculature of the brain in sufficientdetail to understand the invention. The brain 3 is supplied with bloodthrough the carotid and the vertebral arteries on each side of the neck.The important arteries include the common carotid artery 4 in the neck,which will be the most common access pathway for the stent, the internalcarotid 5 which supplies the opthalmic artery 6. The external carotid 7supplies the maxillary artery 8, the middle meningeal artery 9, and thesuperficial temporal arteries 10 (frontal) and 11 (parietal). Thevertebral artery 12 supplies the basilar artery 13 and the cerebralarteries including the posterior cerebral artery 14 and the circle ofWillis indicated generally at 15. Also supplied by the internal carotidartery are the anterior cerebral artery 16 and the middle cerebralartery 17, as well as the circle of Willis, including the posteriorcommunicating artery 18 and the anterior communicating artery 19. Thesearteries typically have an internal diameter of about 1 mm to 5 mm, mostcommonly from 2-4 mm. The methods and devices described herein allowaccess to these arteries and placement of a stent in these arteries. InFIG. 1, the insertion catheter 2 and stent 1 are shown threaded throughthe common carotid artery 4 and the internal carotid artery 5, with thestent extending into the anterior cerebral artery 16.

[0037]FIG. 2 shows the same blood vessels in a schematic view thatbetter illustrates the circle of Willis and the arteries which supplythis important anatomic feature. The circle of Willis 15 is a ring ofarteries connecting the internal carotid arteries and the basilar artery(and hence the left and right vertebral arteries) to the anteriorcerebral arteries 16, middle cerebral arteries 17 and posterior cerebralarteries 14. The system provides a redundant supply of blood to thecerebral arteries. Aneurysms, fistulas, AVM's and tumors occurringinside the brain, in the intracranial portion of the carotid arteries,vertebral arteries and basilar artery, in the circle of Willis or evendeeper within the brain may be treated with the stents and deliverysystems described below. FIG. 2 shows an exemplary use in which adelivery catheter 2 is inserted through the aorta into the commoncarotid, internal carotid and through the circle of Willis 15 into themiddle cerebral artery 17 to treat an aneurysm 65 with a stent which isheld on or within the distal tip of the delivery catheter.

[0038]FIG. 3 shows the overall structure of the stent 1, when mounted inthe delivery catheter 2. The stent 1 is comprised of a single sheet 20of Elgiloy™, stainless steel, nitinol, plastic or other suitablematerial. The metals are processed so as to provide a high level ofspring property. Such processing includes cold rolling and suitable heattreatment. The stent is rolled tightly around the insertion catheterdistal tip 21. Retaining clip 22 holds the sheet in a tight roll aroundthe catheter. The retaining clip or tab is operated by pull wire 23which extends out the proximal end of the catheter. The retaining tab isslidably disposed within the arcuate side lumen 24 and extends distallyfrom the side lumen to hold the stent in a tight roll on the distal tipof the catheter. The retaining clip or tab 22 is operably connected tothe proximal end of the catheter via a pullwire so that the retainingtab may be pulled proximally into the arcuate side lumen to release thestent. The clip mechanism provides for a lower profile than theconstruction of other stents such as the Winston stent and the Lanestent which require spools or sheaths. In another embodiment, anelectrolytic charge may be used to release a securing attachment to thestent, thus allowing for stent expansion and/or release from thecatheter. The clip may be made of tantalum or other radiopaque materialso that it is clearly visible under fluoroscopy. The outer diameter ofthe stent, when rolled tightly around the distal tip of the catheter,will typically be 1-3 French (0.3 mm to 1 mm), and may be as small as 1French, about 0.3 mm (0.012 inches or 12 mil), or even smaller. Thestent may also be coated with radio-dense material (tin, tantalum, etc.)to enhance visibility under fluoroscopy. Also, radiopaque markers oftantalum, platinum or gold may be attached to the stent.

[0039]FIG. 4 shows the cross section of the insertion catheter 2 withthe stent 1 mounted and retained by the retaining clip 22. The retainingclip has a circumferential radius matching the outer diameter of therolled stent, and may be pulled by pullwire 23 into the arcuate sidelumen of the insertion catheter. Upon pull-back of the retaining clip,the stent will release and unroll or unwind to a diameter of about 1 mmor less, or as much as 5 or 6 mm. After release, the stent will have atleast one layer in the unwound state. A single layer may partially coverthe interior surface of the blood vessel wall (see FIGS. 19 and 20), maycompletely cover the surface with a single layer of stent material, ormay cover the interior surface with more than one layer of stentmaterial. Use of multiple layers provides extra columnar and radialstrength (i.e., resistance to compression or resistance to unwinding orre-rolling in response to compressive forces) vis-à-vis a single layer,and this extra strength is beneficial in view of the modifications ofthe stent as described below to enhance the radial and longitudinalflexibility of the stent. Another embodiment allows for a single layerstent across the vessel anomaly to be occluded and one or more layers atthe stent vessel anastomosis site (the endpoints of the stent).

[0040]FIG. 5 shows a cross section of the stent 1 mounted in aninsertion catheter sheath 25. The stent is tightly rolled within thedistal tip of the catheter sheath and it is delivered to the target sitewithin the distal tip of the delivery sheath. A push rod 26 with anoptional central lumen 27 and a distal face 28 abuts the proximal end ofthe rolled stent. In order to insert the stent within the blood vessel,the push rod 26 is used to hold the stent in place while the cathetersheath is retracted proximally to uncover the stent, or it is used topush the stent out from the sheath. Once the stent is free of thecatheter sheath, it will unroll until it meets the inner wall of theblood vessel. FIG. 6 shows a cross section of a delivery catheter whichprovides both distal and proximal release mechanisms. The stent 1 istrapped between the push rod 26 and the distal retainer 29. Thereceiving bore 30 of the retainer 29 closely matches the outer diameterof the rolled stent. The internal diameter of the catheter sheath 25also closely matches the outer diameter of the rolled stent. Theexternal diameter of the delivery catheter is only slightly larger thanthe outer diameter of the tightly rolled stent. The stent is rolledtightly and trapped within the bore of the distal retainer. The distalretainer is controlled by control rod 31 which extends the length of thecatheter and passes through the central lumen of the push rod 26.Preferably, the retainer control rod has an outer diameter significantlysmaller than the inside diameter of the tightly rolled stent, so that itdoes not interfere with flexing of the stent during deployment. Theretainer control rod may instead have an outer diameter equal to theinner diameter of the rolled stent, so that the stent is directly rolledaround the control rod and the control rod functions as a spool or coreto support the rolled stent. This delivery catheter is operated byreleasing either the proximal or distal end of the stent throughappropriate movement of the distal retainer, the push rod, or thecatheter sheath. The stent may be released distal end first by pushingthe retainer control rod in the distal direction to release the stent,or it may be released proximal end first by pushing the pushing rodforward and distally out from the catheter sheath or withdrawing thecatheter sheath in the proximal direction to release the proximal end ofthe stent. The need for proximal-end-first or distal-end-first releasewill be determined during surgery, and will be accomplished as medicallyindicated.

[0041] The push rod 26 must fit within the catheter sheath with veryclose tolerances to ensure that the rolled stent is uniformly pushedfrom the catheter sheath and the outer roll of the stent cannot getcaught between the push rod and the catheter sheath. Thus, the distaltip 32 of the push rod is enlarged relative to the proximal portion 33of the push rod so that the distal face of the push rod has a diameterwhich closely matches the inner diameter of the catheter sheath. Thedistal face 28 of the push rod is provided with a beveled rim 34 aroundthe outer circumference the distal face to force the stent topreferentially slip toward the center of the distal face and away frompossibly interfering positions between the push rod and the cathetersheath. A beveled rim 35 may be applied also to the inside bore of thepush rod (FIG. 6) to prevent the inner roll of the stent from slippinginto the push rod center lumen and getting caught between the push rodand the distal retainer control rod. FIGS. 4, 5 and 6 thus illustratemeans of securing the stent to the distal end of a catheter andretaining the stent in the tightly rolled configuration duringinsertion, and two means of inserting the stent into the blood vessel.Other means for retaining the stent include rings, pull-strings, stringwraps, bars, and a catheter sleeve and electrolytic fusible joint orfusible link.

[0042] The stent may be a simple rolled sheet of Elgiloy™, nitinol,stainless steel or other resilient material. Elgiloy™ is preferredbecause it is less likely for the inner layer of the tightly rolledstent to take a set or become creased or crimped, which may occur in astainless steel roll when the inner layer of the stent is tightly rolledin its deployment configuration. Plastics, bioabsorbable materials, andother materials may also be beneficially used. Polyesters,polypropylene, polyethylene, polylactic acid and polyglycolic acid arecontemplated alternative materials for the stent.

[0043] The basic embodiment comprises a sheet of Elgiloy™ about 0.0025to 0.025 mm thick (0.1 mils to 1 mil, or 0.0001 to 0.0010 inches).Referring to FIG. 7, the wrap length represented by transverse edge 36will be about 6-75 mm, allowing the stent to expand to diameters fromabout 1 mm to about 6 mm with approximately two to three layers afterexpansion. The bridge length represented by axial edge 37 (or thelongitudinal edge) will vary according to the width of the aneurysmwhich must be isolated with the stent, and may vary from 2 to 20 mm, forexample. The stent is tempered or formed so that it resiliently unrollsand expands to a diameter of approximately 1 mm to 6 mm, and provides aslight compliance mismatch with the intra-cranial arteries which haveinternal diameters of about 1 mm to 6 mm. When expanded, the stentintended for most intracranial applications will comprise a tube of oneto three rolled layers. The stents described above can provide expansionratios of five to one or greater. Expansion ratios of less than five toone may be achieved if desired. For particular intracranialapplications, stents having more than three layers may be used. Stentscomprising less than a single layer when unrolled will also be useful,as illustrated below in reference to FIG. 18.

[0044] The stent will be more flexible, and easier to bend around thevarious twists and turns of the blood vessels, if modified according toFIGS. 8 through 12. The stent may have a thickness which graduallyincreases along the transverse edge, as shown in FIG. 8. When the stentis expanded, the material of the inner layers is thinner than the outerlayers. Thus, the inner edge 38 is thinner than the outer edge 39. Thisconstruction permits the stent to flex sideways even when rolled tightlyto the distal tip of the insertion catheter and mitigates the tendencyof the innermost edge of the stent to be permanently deformed in itsrolled down state. The inner edge may be as small as 0.0025 mm (0.1mil), and the thickness can gradually thicken to 0.05 mm (2 mils) at theouter edge. In FIG. 14, the stent is modified with the provision of ribs40 that extend transversely across the width of the rolled sheet, or ata slight angle to the transverse edge. The wall thickness in theinterstitial portions between the ribs may be quite thin, less than0.0025 mm (0.1 mil), and yet the stent has sufficient resilience toexpand into its open configuration and exert pressure against the innerwall of a small blood vessel. This property will allow the stent toremain in position and maximize the sealing characteristics of thedevice. The ribs may be applied only at the distal and proximal ends ofthe stent, and may be integrally formed as gradually increasing stentthickness.

[0045]FIG. 9 shows the stent 1 modified by excision of numerous cutaways41, 42 and 43 leaving slats or ribs 44, 45, and 46 in eventual outerlayer 47, middle layer 48 and inner layer 49. The segments of slats areseparated by spines or backbones 50. The slats of each segment areoffset so that, when expanded to a roll of approximately three layers,the three layers will overlap to form a barrier between the blood vesselwall and the inner lumen of the expanded stent. The slats shown in FIG.9 are disposed laterally, aligned in the transverse direction across thewidth of the stent sheet, parallel to the distal transverse edge 51 orthe proximal transverse edge. Of course, where the distal and proximaledges are not straight edges (such a construction may assist attachmentto the blood vessel), the slats and cutaways can be described asparallel to the transverse axis of the stent sheet. The stent may bemade with at least one, but preferably two layers instead of the threelayers used for illustrative purposes herein, or four layers or more,and the number of layers will dictate the spacing of the slats and thecutaways. The slatted construction provides longitudinal flexibility byremoving part of the material from the wall of the stent.

[0046] As shown in FIG. 10, the slats may be disposed at an angle fromthe transverse direction and still create a barrier between the bloodvessel lumen and the outer surface of the stent. In the outer layersection 47 of the stent, the slats are disposed at an angle, shown atangle of about 45° from the transverse direction. The angle of 45° isshown as one of the preferred embodiments but is to be considered merelyillustrative of the infinite number of possible arrangements. In themiddle layer section 48 of the stent the slats are disposed at anopposing angle, again shown merely for illustration to be about 45° fromthe transverse direction, but opposite the angle of the slats in theouter layer section. These two layers, when overlapping, will provide anearly imperforate roll, with passages through the wall of the stentonly at the intersections of the cutaways. These passages are, however,blocked by the transversely oriented slats of inner layer section 49.The slats are sized and dimensioned to ensure that, when expanded withinthe target vessel, the three layers together form a barrier between theoutside of the stent and the inside of the stent. Thus if perfect threelayer overlap and alignment were expected, each slat could be of equalsize and the transverse inner layer slats 46 could be the same width asthe passage created by the intersection of the cut-away slots in theother layers. However, to allow for an imperforate wall when the layersare not perfectly aligned and perfectly overlapping in three layers, theinner layer slats 46 are made slightly wider than the correspondingcutaways on the outer and middle layers. The dashed line 52 shown inFIG. 10 illustrates that the center point of cutaway 41 a and 42 b willintersect when the stent is rolled in three layers, and that slat 46 awill correspond to the intersection and block the gap created by theintersection of the two diagonal slots.

[0047]FIG. 11 shows that numerous patterns of cutaways may be conceivedto provide a multi-layered stent wherein each layer contains pluralityof slots or perforations, but, when rolled so that the layers aredisposed in concentric arrangement, the layers combine to form animperforate wall. In the outer layer section, the slots are aligned onan angle from the transverse axis, while the slots in the middle layerare arranged at an opposing angle relative to the slots on the outerlayer. The numerous slots on the inner layer are arranged so as tocorrespond to the areas of overlap of the outer and middle layer,leaving the slats to cover the open areas where the slots of the middleand outer layers overlap. Thus, FIG. 11 illustrates that the number andarrangement of slots may be highly variable while still providing animperforate overall construction with highly perforate walls.

[0048]FIG. 12 is provided as an illustration of the concept. It is moreclearly demonstrated in the simple embodiment of FIG. 12 that thecutaways 53 a, 53 b and 53 c on the outer layer and the cutaways 54 a,54 b and 54 c will, when the outer layer is rolled over the middlelayer, intersect along lines 55 a, 55 b and 55 c. The slats 56 a, 56 band 56 c on the inner layer are intersected by lines 55 a, 55 b and 55c, and correspond to the expected gap created by the intersection of thediagonal cutaways. The inner section slats may be made larger that theexpected gap created by the diagonals to ensure blockage of the gap whenthe roll is either looser or tighter than exactly three layers, ormisaligned. The concept may be applied to any number of layers, thegeneral rule being that the slats of each layer, when rolled over top ofeach other, form an imperforate wall. Thus, the longitudinal flexibilityof the tightly rolled stent is promoted by ribbed or slattedconstruction (or, alternatively, slotted construction) in which thevarious layers of the stent are provided with numerous slats whichcounter align when the stent is expanded to form an imperforate wallfrom a plurality of perforate layers.

[0049] The backbones 50 created between the slatted sections can bearranged so that they are aligned when the stent is tightly rolled, toprovide increased flexibility during insertion. The backbones may alsobe created so that they are aligned when the stent is unrolled anddeployed within the blood vessel to provide extra flexibility whenunrolled in the install configuration. Careful selection of the tightlyrolled size will permit alignment of the backbones during both the tightrolled insertion configuration and the loosely rolled deployedconfiguration. For example, if the diseased vessel for which the stentis intended is about 2 mm in inner diameter, it will have an innercircumference of about 6.3 mm (2 mm×π). A stent designed for this sizevessel may have one or more segments with backbones spaced about 6.3 mmapart, so that when unrolled each segment will cover one entirecircumference, and the backbones will all be on one side of the vessel.When rolled tightly to fit within the sheath or upon the distal tip ofthe catheter (as shown in FIGS. 4 and 5), the stent may be rolled to adiameter of 1 mm or 0.5 mm (or, for example, in relation to thepreferred embodiments, any integer fraction ½, ⅓, ¼ . . . of thedeployed diameter, and realizing that other relationships will apply toother embodiments), so that the backbones are layered upon each other.Thus all the backbones are disposed on one side of the roll in both thedeployed diameter and the tightly wound diameter.

[0050]FIG. 13 shows another embodiment of the ribbed stent. In thisembodiment, a single backbone 50 supports several ribs 57 which areunrestrained at the outer edges of the ribs. The ribs are flat and wide,with gaps 58 on one side of the backbone which are offset from the gapson the other side of the backbone. When rolled into a tight roll (upon acatheter distal tip or inside a sheath, as illustrated in FIGS. 4 and5), or unrolled within a blood vessel, the ribs overlap each other andform an imperforate wall. The ribs on one side of the backbone arealigned with the interstitial gaps on the other side of the backbone,thus creating an interfering pattern in much the same manner asdescribed above in relation to FIG. 9. The backbone is the only regionof this stent that is continuous from the distal end of the stent to theproximal end of the stent, and this eliminates much of the resistance tolongitudinal flexibility and allows the stent to be bent around tightcurves in the vasculature without crimping or creasing.

[0051] Note that by shifting any segment of slots upward or downward,the rolled stent will have a loosely rolled deployed configuration inwhich the walls of the stent are perforated. Thus, in reference to FIGS.9, 10, 11 or 12, the gaps closed by the slats of the third segment asdescribed above may be maintained open by shifting slats upward ordownward slightly so that they no longer block the gap. Construction ofsuch a perforate multi-layered stent will allow flexibility of the stentin the undeployed and deployed configuration, provide for perforationsallowing vessel ingrowth, better retention of the stent, or ability topass blood into perforating vessels, yet still provide for the extraresistance to compression afforded by multiple layers.

[0052] The slots provided in the wall of the stent may be locallyenlarged to create regions of highly perforate wall in the stent. Thismay be medically indicated when it is desired to maintain patency of thenumerous side branches and perforator blood vessels which are suppliedwith blood by the typical intra-cranial blood vessel. In reference toFIG. 13, the circumferentially extending ribs on either side of thebackbone 50 may be aligned so that the ribs on one side overlap the ribson the other side, thereby creating openings in the wall of the deployedrolled stent which correspond to the open areas 58 between the ribs 57.This configuration is shown in FIG. 13a. The stents of FIGS. 9 through12 may be modified accordingly, providing regions of relatively largerslots which prevent occlusive overlap of the slats, thereby maintainingpatency of many side branches and perforating blood vessels fed by thestented blood vessel. This may be achieved with broad backbones andnarrow slats of minimal width relative to the slots, so that occlusionis achieved only along the overlapping backbones. It may also beachieved by providing some of the slatted areas of a stent constructedaccording to FIG. 11 with overlapping and occluding dimensions whileproviding other slatted areas with dimensions which result in a highlyperforate, non-overlapping or completely patent structure in the looselyrolled deployed configuration.

[0053] Another embodiment of the rolled stent is shown in FIG. 15. Thisstent is a variation of the slatted stent illustrated above. The slatsare aligned longitudinally in relation to the catheter and blood vessel,and perpendicular to the transverse edge or wrap length 36. The slots41, 42, and 43 are narrow relative to the slats 59, 60, 61 and 62. Tocreate a loosely rolled stent in a substantially imperforate wall fromthis stent, the wrap length 36 is several times longer than thecircumference of the target blood vessel. When the stent is looselyrolled to approximate the inner diameter of the blood vessel lumen, thegaps between longitudinally oriented slats in one layer will be blockedby the slats in other layers. Occlusion of the stent wall will occur forall vessel circumferences which are approximately equal to the distancebetween the center of one slat and the center of one slot. Thus animperforate wall is formed from this highly perforate embodiment of therolled sheet stent for vessels with diameters corresponding to lengthsC₁, C₂, and C₃, equivalent to the distance from the reference slat 59 tothe center of each of the various slots. The bar-bell shape of the slots(cutaway portions) creates fusiform or tapered shaped slats joined tothe end bands 63 provides additional flexibility for the stent whentightly rolled to fit within (or upon) the distal tip of the deliverycatheter.

[0054] In relation to each of the embodiments described above, the stentmay be configured to provide a section (either an arcuate segment or alongitudinal segment, which is substantially imperforate, while theremaining portions of the stent are substantially perforate or open.This allows for occlusion of the aneurysm or target site of diseasewhile permitting flow of blood between the vessel wall and the bloodvessel lumen in other areas of the stent. This allows blood flow to anybranch blood vessels or perforator blood vessels which supply blood tothe brain. The “H” shaped stent of FIG. 21 accomplishes this, andvariations on the alignment of the slot patterns on the multi-layeredstents of FIGS. 8 through 12 will accomplish such an arrangement.

[0055] All of the stent configurations are intended for use whilevisualized under fluoroscopy. Fluoroscopy will also be used to view thestent during follow-up to ensure continued proper placement. Thus thestent may be coated with radiopaque material such as tantalum to enhancevisibility under fluoroscopy. The stent may be coated with a number ofsubstances which help prevent thrombus or coagulation of blood aroundthe stent or in the nearby blood vessel which may be affected by thestent. Paralyne, polyurethane, polyester, polyphosphazene, Dacron,Nylon, silicone, polymers and biopolymers, heparin and albumin coatings,negative ion coatings, tin, and acids such as polylactic acid andpolyglycolic acid may be used. Various medications may be bound to thecoating, and medications such as heparin, methotrexate, forskolin arecontemplated for use. The surface of the stent may also be mademicroporous with perforations of, for example, about 0.001″ diameter toenhance the vessel ingrowth into the stent for better stent/vesselattachment and to improve thrombogenicity.

[0056] The stent is placed with the insertion catheter into an arterywithin the skull or brain, such as the many arteries pointed out inreference to FIG. 1. The catheter is inserted into a blood vessel of apatient, typically the femoral artery, and the distal tip with the stentmounted thereon is steered into an intra-cranial blood vessel of thepatient. In the close-up view of FIG. 16, the stent is shown in anartery exhibiting an aneurysm which could rupture or lead eventually toocclusion, both life threatening events. The blood vessel 64 includes asaccular aneurysm 65. The aneurysm and aneurysm neck may vary in size.Small aneurysms are those of 0-10 mm diameter. Large aneurysms are 10-25mm in diameter, and giant aneurysms are greater than 25 mm in diameter.Distance a represents the size of the aneurysm neck. In clinicaldiscussion, a wide-neck aneurysm has a neck which exceeds 4 or 5 mm. Thestents described herein may be used with aneurysms of all sizes.

[0057] The placement of the stent 1 straddles the aneurysm. Once in thediseased portion of the intra-cranial artery, the stent is maneuveredinto place in the proximity of the aneurysm, with the stent straddlingor bridging the neck 66 of the aneurysm. Once in position, the retainingclip is pulled back into the side lumen thereby releasing the stentwithin the intra-cranial artery. The solid walled stent, or the modifiedstent, unrolls to form an imperforate barrier between the arterial walland the center of the stent, and immediately isolates the sac 65 fromthe blood vessel lumen 67. This is shown in FIG. 17, in which the stenthas unrolled from an original tightly rolled configuration shown in FIG.16 to a partially unrolled configuration with three layers of stentmaterial.

[0058] Upon placement of the stent, the blood flow is redirected fromthe target opening and the aneurysm is isolated from the high bloodpressure of the vascular system, and the threat of hemorrhage iseliminated. In this manner, a patient showing signs of acute distressfrom a cerebral aneurysm may be treated immediately in a manner thatstops or prevents rupture and hemorrhage. Placement of the stentimmediately seals off the aneurysm to protect against bleeding orrupture, in contrast to prior art open walled stent placements used inlarger peripheral arteries which require significant time for theformation of fibrous tissue within the aneurysm and formation ofendothelial cells to create a barrier which isolates the aneurysm fromthe high pressure of the vascular system. Gradual retraction of theaneurysm or tumor after exclusion and resultant lack of blood flowshould relieve any mass effect caused by the size and pressure of theaneurysm or tumor against other structures in the brain.

[0059] The stent may be left in place as the permanent treatment for theaneurysm or target vessel, or it may be used as a temporary means ofre-directing blood flow for stabilizing a patient while considering oractually performing more invasive treatment. Aneurysm clipping, which isone of the standard treatments for intra-cranial aneurysm, is plagued bythe risk of rupturing the aneurysmal sac during the surgery. As shown inFIG. 17, the aneurysm may be clipped in accordance with known procedureswhile the stent is in place. To place the clips, the brain must beexposed and dissected away from the aneurysm so that the clips may beplaced at the base of the aneurysm. Rupture during surgery makes thesurgery more difficult, decreases visibility and requires additionaldissection, contaminates the brain with blood, and makes it moredifficult to seal the aneurysm with the clips. With the stent 1 expandedwithin the blood vessel, the brain is dissected away from the aneurysmto expose the outside 68 of the aneurysm. Clips 69 (shown in FIG. 17)may be placed at the, neck of the aneurysm and squeezed closed upon theaneurysm, thereby further sealing the aneurysm sac from the bloodvessel. After the aneurysm has been successfully clipped and therebyisolated from the high pressure of the blood vessel, the stent may beremoved from the lumen of the blood vessel. FIG. 18 shows that the stentmay also be used to immediately isolate the aneurysm after placement ofGDC's. Several Guglielmi detachable coils or other such detachable coils70 are shown inside the aneurysm sac 65. The coils will, in the usualcase, eventually cause coagulation and clotting within the aneurysm.However, the patient is at risk during the period required forsuccessful development of the occluding mass caused by the bodiesreaction of the coils. To ensure immediate isolation of the aneurysmfrom the blood vessel, and to ensure that the coils do not escape theaneurysm sac and float downstream to cause embolization or clotting inhealthy portions of the blood vessel, the rolled stent is deployedimmediately before or after placement of the coils. When used in thismanner, the stent is used as an adjunctive to surgery to make it saferand eliminate the complications arising from invasive surgery. In caseswhere a patient is presented in an emergency condition, perhapssuffering from a ruptured intracranial aneurysm, immediate placement ofa solid walled or slightly perforate stent may be the only way to savethe patient's life while preparing for other surgery. Placement of coilsmay be accomplished through the wall of the stent, where the stent isslightly perforate (with a high metal to vessel wall ratio) or where thecoils may be pushed into the aneurysm through slots in the wall of animperforate stent constructed according to FIGS. 9-16.

[0060]FIG. 19 illustrates another embodiment of the stent as well asanother method of using the stent to isolate an aneurysm 65 from theblood stream. The stent 1 has been inserted into the blood vessel 64 andcovers the opening of aneurysmal sac 65. A blood vessel 71 (it may be abranch that is supplied by blood vessel 64 or it may supply blood vessel50) joins blood vessel 64 near the aneurysm. A rolled stent whichunrolls to cover all 360° of the blood vessel inner wall will cover boththe aneurysm and the blood vessel 71, but it is usually desirable tomaintain flow to or from this blood vessel. In this case, a stent 1 witha short wrap length is used. The stent has a wrap length which isshorter than the internal circumference of the blood vessel, so thatwhen unrolled within the blood vessel it expands to meet the inner wallof the blood vessel but covers less that the entire circumference of theblood vessel wall. The elasticity and spring force of the stent willhold it in position against the blood vessel wall and isolate theaneurysm from the blood vessel. FIG. 20 illustrates another situationwhere the resilient half stent is used. The blood vessel and branchblood vessel are normal and healthy. Another branch vessel 72 suppliesblood from the main blood vessel 64 to a diseased area 73. The diseasedarea may be an aneurysm or fistula in the branch blood vessel, a tumorsupplied by the branch blood vessel, or any other vascular disease. Thehalf stent has been released within the main blood vessel 64 so that itblocks blood flow to the branch blood vessel, thereby isolating thediseased area from the blood stream. The diseased area will necrose andbe absorbed by the body over time, thereby alleviating the conditionwithout surgery directly in the area of the disease.

[0061] When used in this manner in a perfectly round blood vessel, thestent must have a wrap length of at least half the inner circumferenceof the blood vessel so that it covers at least 180° of the inner wall ofthe blood vessel. However, in a real blood vessel which is not perfectlyround, it may be sufficient that the wrap length be about half the innercircumference of the blood vessel, and cover about 180° of the innerwall, and coverage of at least 180° will be useful in a wide range ofblood vessels. In use, it will be most practical to select a wrap lengthwhich results in about 210° to 270° of coverage (with wrap lengthcorresponding to about ¾of the expected inner wall circumference), toensure a good fit, adequate resilience for expansion and holding power,and sufficient clearance for the branch blood vessel.

[0062] The half layer stent shown in FIGS. 19 and 20 may be provided asa single imperforate sheet, or it may include any pattern of slots asillustrated in FIGS. 6-9. The half layer stent should be mounted on thecatheter distal tip (FIG. 4) or within the catheter sheath (FIG. 5) sothat it is properly aligned with the side branch or aneurysm to beblocked. The retaining clip made of tantalum or a tantalum marker on thesheath will provide the reference point for the surgeon duringplacement, so that rotational and longitudinal alignment with thesemarkers will allow proper release and placement of the stent. The rolledstent may be centered under the retaining clip so that the clipcorresponding to the side of the vessel where the stent is to be placed.

[0063]FIG. 21 shows another variation of the stent. This stent is shapedlike the letter “I” or the letter “H.” The backbone 50 is augmented withintegrally formed ribs or tabs 74 a, 74 b, 74 c and 74 d extendingtransversely from the backbone at the distal and proximal ends of thestents. The transversely extending tabs create open areas 75 Thetransverse edge preferably exceeds the circumference of the blood vesselin which the stent is inserted. The single backbone will provide theoccluding surface area of the stent, while the ribs serve to provideradial expansive strength for the stent to provide stronger deploymentand holding resilience.

[0064] As shown in FIG. 22, the loosely rolled deployed configuration ofthe stent has the backbone 50 occluding the target vessel 72, while theribs or tabs extend circumferentially over the entire circumference ofthe blood vessel to hold the stent in place. The ribs may overlapsomewhat, as shown, creating an arcuate open space 75 in what wouldotherwise be the wall of the stent. Branch blood vessel 71 is notoccluded because the stent is placed so that the cutaway portions of thestent overlie the opening into the blood vessel 64. Thus, in use, thestent provided with an occluding sheet with transversely extendingretaining bands on the distal and proximal ends is placed within theblood vessel so that the occluding sheet occludes a diseased branchvessel, aneurysm or other AVM while circumferential portions of theblood vessel opposing the occluding diseased branch vessel, aneurysm orother AVM are not covered by the occluding sheet, thereby allowing bloodflow between the blood vessel and any branch blood vessel communicatingwith the blood vessel at a site opposite the occluding sheet.

[0065]FIGS. 23 and 24 illustrate another embodiment of the rolled sheetstent. This stent takes the shape of an open frame with an open centralarea 76. Side-frame pieces 77 a and 77 b will provide the occludingsurface for this stent, and distal end and proximal end pieces 78 willprovide radial support for the stent. When rolled within a blood vesselas shown in FIG. 24, the overlapping side frame pieces occlude thediseased branch vessel, aneurysm or other AVM designated generally atitem 73. As with the stent of FIG. 21, this stent is placed within theblood vessel so that the open portion overlies the healthy branch vessel71 while the occluding sheet made up in this instance of side framepieces covers the diseased blood vessel 72. In FIG. 24, severalperforator vessels 79 are shown to illustrate that there will typicallybe several perforators left open and un-occluded by the open area of thestent, while other perforators, such as perforator 80, may be occludedby the stent. In the deployed configuration, the stents of FIGS. 22 and24 will appear to be very similar, comprising an arcuate occludedsegments and an arcuate un-occluded segments. The occluded segment iscreated by the spine 50 in FIG. 22 or side pieces 77 a and 77 b in FIG.24, and the un-occluded segment is created by the central opening 75 or76.

[0066] Catheter placement may be facilitated with the use of commonguide catheters and guide wires. Expansion of the stent may be aided bya micro-balloon placed at the tip of the insertion catheter. Otherfeatures described, such as the materials of the stent, the arrangement,number and degree of openings or slats, and geometry of the release tabmay be improved upon as experience with the devices and methodsdescribed above dictates. Thus, while the preferred embodiments of thedevices and methods have been described, they are merely illustrative ofthe principles of the invention. Other embodiments and configurationsmay be devised without departing from the spirit of the inventions andthe scope of the appended claims.

We claim:
 1. A stent for isolating a diseased portion of a vessel withinthe body, where the vessel is connected to branch vessels in closeproximity to the diseased portion, said stent comprising an open framewith a plurality of frame members, where at least one frame member issized and dimensioned to occlude the diseased portion of the vessel, andan opening between the frame members is sized and dimensioned to overliethe branch vessels when the stent is placed within the vessel.
 2. Astent comprising a generally tubular walled structure having asubstantial un-occluded opening in the wall of the stent, where saidopening spans a substantial arcuate segment of the stent.
 3. A tubularstent for intra-cranial use, said stent comprising: a sheet of resilientmaterial having a first edge, a second edge, a third edge, a fourth edgeand a spine extending from the third edge to the fourth edge, said spinebeing generally parallel to the first and second edges; wherein thefirst edge has a first rectangular-shaped open section disposed withinthe first edge, said first rectangular-shaped open section sized anddimensioned to extend from the spine to the first edge, and to a firstdistance from the third edge and a second distance from the fourth edge;wherein the second edge has a second rectangular-shaped open sectiondisposed within the second edge, said second rectangular-shaped opensection sized and dimensioned to extend from the spine to the secondedge, and to the first distance from the third edge and the seconddistance from the fourth edge; wherein the sheet of resilient materialis tightly rolled about an axis parallel to the first and second edgesto form a tightly rolled stent, said tightly rolled stent having adiameter less than 1 mm and expandable to a diameter of approximately 1mm; wherein the tightly rolled stent is expandable to a diameter ofapproximately 1 mm to provide slight compliance mismatch with anintra-cranial blood vessel having an internal diameter of approximately1 mm; and when expanded the stent comprises two rolls with a pluralityof layers, said rolls connected by the spine.
 4. A stent for use withina vessel of the body, said stent comprising a sheet of resilientmaterial having a wrap length corresponding to the circumference of thevessel and a bridge length corresponding to the long axis of the vessel,wherein the wrap length of the sheet is less than the circumference ofthe vessel, and the bridge length is sufficient to extend longitudinallyin the vessel to isolate a diseased portion of the vessel, said sheetbeing capable of taking on a curvature conforming to the curvature ofthe vessel.
 5. The stent of claim 4 further comprising at least onecircumferentially extending tab which takes on the curvature of thevessel.
 6. The stent of claim 4 further comprising a first tab extendingcircumferentially from a first end of the stent and second tab extendingcircumferentially from the first end of the stent in a directionopposite the first tab, said first and second tabs and stent having acombined wrap length exceeding the circumference of the vessel.
 7. Thestent of claim 6 further comprising a third tab extendingcircumferentially from a second end of the stent and fourth tabextending circumferentially from the second end of the stent in adirection opposite the third tab, said third and fourth tabs and stenthaving a combined wrap length exceeding the circumference of the vessel.8. A stent for use within a vessel of the body, said stent comprising asheet of resilient material having a shape corresponding to a capitalletter “H”, wherein the wrap length of the stent corresponds to thecircumference of the vessel.